CancerPhase 1/2NCT07059832
Application of 68Ga-NODAGA-SNA006 Positron Emission Tomography/Computed Tomography (PET/CT) in Tumors
A Phase 1/2 study testing 68Ga-NODAGA-SNA006 in people with Cancer, run by First Hospital of China Medical University at 1 site in China.
Trial summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- 68Ga-NODAGA-SNA006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who were diagnosed with malignant tumors;
- Patients are between 18 and 80 years of age are between 18 and 80 years of age.
Who cannot join
- Participants who were unable or unwilling to provide written informed consent.
- Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of 68Ga-NODAGA-SNA006 in Patients With Solid Tumor or Lymphoma
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.
Read the detailed description
The aim of this study was to explore the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in patients with solid tumors or lymphoma.
- Conditions
- Cancer
- Being tested
- 68Ga-NODAGA-SNA006
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-SNA006Drug
68Ga-NODAGA-SNA006 PET/CT: after intravenous injection of 0.05 mCi/kg body weight of quality-controlled 68Ga-NODAGA-SNA006, an integrated PET/CT scanner (Biograph mCT; Siemens, Germany) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and safety of 68Ga-NODAGA-SNA006 | Experimental | 68Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days Receives: Drug: 68Ga-NODAGA-SNA006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events
Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum
Measured: 3 YEAR
Biodistribution of 68Ga-NODAGA-SNA006
Through PET/CT analysis, SUVmax and SUVmean of the organs
Measured: 3 YEAR
Secondary outcomes (1)
Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype
Correlation coefficients (r²) between SUVmax and SUVmean measured by PET/CT and immunophenotypes
Measured: 3 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Apr 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxuan Zhao, First Hospital of China Medical University
- Investigators
- li, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059832
- Sponsor's protocol ID
- [2024]1161
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 68Ga-NODAGA-SNA006 in Patients With Solid Tumor or Lymphoma
- ClinicalTrials.gov ID
- NCT07059832
- Acronym / sponsor ID
- [2024]1161
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.
Detailed description
The aim of this study was to explore the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in patients with solid tumors or lymphoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility and safety of 68Ga-NODAGA-SNA006 | Experimental | Drug: 68Ga-NODAGA-SNA00668Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who were diagnosed with malignant tumors;
- Patients are between 18 and 80 years of age are between 18 and 80 years of age.
Key exclusion criteria (2 listed)
- Participants who were unable or unwilling to provide written informed consent.
- Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-SNA00668Ga-NODAGA-SNA006 PET/CT: after intravenous injection of 0.05 mCi/kg body weight of quality-controlled 68Ga-NODAGA-SNA006, an integrated PET/CT scanner (Biograph mCT; Siemens, Germany) will be applied. | Drug | Feasibility and safety of 68Ga-NODAGA-SNA006 |
Primary outcome
Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events
Time frame: 3 YEAR
Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum
Biodistribution of 68Ga-NODAGA-SNA006
Time frame: 3 YEAR
Through PET/CT analysis, SUVmax and SUVmean of the organs
1 secondary outcome
Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype
Time frame: 3 YEAR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li study director
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-NODAGA-SNA006 in people with Cancer, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events (time frame: 3 YEAR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.